Validation of a cell-based colorimetric reporter gene assay for the evaluation of Type I Interferons

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dc.contributor.affiliationUnidad de Desarrollo e Investigación en Bioprocesos, Instituto Politécnico Nacional (IPN), Unidad Profesional Lázaro Cárdenas, Ciudad de México, México
dc.contributor.emailsperezt@ipn.mx (S.M. Pérez-Tapia), emilio.medina@udibi.com.mx (E. Medina-Rivero).
dc.creatorMejía-Calvo, Ignacioes_ES
dc.creatorMuñoz-García, Lesliees_ES
dc.creatorJiménez-Uribe, Alexises_ES
dc.creatorCamacho-Sandoval, Rosaes_ES
dc.creatorGonzález-González, Edithes_ES
dc.creatorMellado-Sánchez, Gabrielaes_ES
dc.creatorTenorio-Calvo, Alejandra V.es_ES
dc.creatorLópez-Morales, Carlos A.es_ES
dc.creatorVelasco-Velázquez, Marco A.es_ES
dc.creatorPavón, Lenines_ES
dc.creatorPérez-Tapia, Sonia Mayraes_ES
dc.creatorMedina-Rivero, Emilioes_ES
dc.creator.identificadorhttps://orcid.org/0000-0002-6067-6868 (Pavón, Lenin)
dc.date2019
dc.date.accessioned2023-01-09T20:06:17Z
dc.date.accessioned2026-03-27T15:25:44Z
dc.date.available2023-01-09T20:06:17Z
dc.date.issued2019
dc.date.published2019
dc.descriptionThe biotherapeutic type I interferons (IFN-I) are indicated to treat several diseases. These products are regulated to guarantee safety and efficacy through critical quality attributes. For this purpose, the development of robust assays is required, followed by its validation to demonstrate their suitability for its intended purpose. Despite there are some commercial kits to evaluate IFN-I signaling, these are focused on measuring in vitro biological response instead of their validation, which is a pharmaceutical industry requirement. The aim of this work was to validate the HEK-Blue IFN-α/β system evaluating the biological activity of IFN-α/β under good laboratory practices, according to international standards. Our results demonstrated that HEK-Blue IFN-α/β system comply with accuracy (r2>0.95) precision (CV < 20%) and specificity for both IFN-α/β; confirming that this assay is robust for this biotherapeutics’ evaluation. Thereby, this bioassay could be implemented as a complementary method to the classical anti-proliferative and anti-viral assays under quality control environments.es_ES
dc.formatPDFes_ES
dc.identifierJC34NC22es_ES
dc.identifier.doi10.1016/j.btre.2019.e00331
dc.identifier.eissn2215-017X
dc.identifier.organizacionInstituto Nacional de Psiquiatría Ramón de la Fuente Muñiz
dc.identifier.placePaíses Bajos
dc.identifier.urihttps://doi.org/10.1016/j.btre.2019.e00331
dc.identifier.urihttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6487280/
dc.identifier.urihttps://repositorio.inprf.gob.mx/handle/123456789/7665
dc.language.isoenges_ES
dc.publisherElsevieres_ES
dc.relatione00331
dc.relation.jnabreviadoBIOTECHNOL REP (AMST)
dc.relation.journalBiotechnology Reports
dc.rightsAcceso Cerradoes_ES
dc.subject.kwBioassay
dc.subject.kwInterferons α/β
dc.subject.kwReceptor binding
dc.subject.kwBiotherapeutic products
dc.titleValidation of a cell-based colorimetric reporter gene assay for the evaluation of Type I Interferonses_ES
dc.typeArtículoes_ES

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